KR20190082678A - System and method for laboratory screening of biological samples - Google Patents

Abstract

System and method for laboratory screening of biological samples
A system and method for guiding management of a blood and / or plasma screening laboratory workflow is disclosed. In some embodiments, a system for analyzing a biological sample includes centrifuges, pooling instruments, biological sample analyzers, and a processor for monitoring the operation of the centrifuge, the pooling instrument, and the biological sample analyzer. The processor can track the progress of the analysis of the biological sample and generate progress indicators through a graphical user interface. In accordance with the determination that an external control is present, the system can prevent the release of biological components into the biological sample analyzing device to perform analysis until the external control is also loaded into the analyzer. Depending on the determination that the components of the biological sample are not to be grouped or pooled into more than one pool, the system may generate an alert via a graphical user interface. The system can provide a chronology of states, display the status of the instrument and biological sample, indicate components requiring operator attention, and retrieve and display the status of samples and tests. The system can prevent unintended use, including redundancy checking.

Description

System and method for laboratory screening of biological samples

Embodiments of the present disclosure may, for example, Systems and methods for laboratory screening of biological samples, including monitoring progress, generating progress indicators, and the like.

Description of Related Technology

Biological (blood and plasma) screening and clinical diagnostics Laboratory testing was a very complex process using multiple instruments, including multiple types of analysis. Each type of assay and instrument may require a special workflow that increases the complexity of the screening and diagnostic test procedures.

There may be islands of steps and sub-workflow steps that a laboratory technician needs to manage. The regulatory body stipulates that screening laboratories must analyze the results of all biological tests from multiple instruments and then decide on the conclusions for the biological samples. The process of collecting all the biological test results for evaluation and determining the conclusions for the biological samples may involve many steps, some of which are typically performed manually by the technician. In addition, laboratory technicians typically track elements, states, and workflows by physically inspecting the islands of each step and sub-workflow stage. Because lab technicians keep records up-to-date manually, tracking the status of all devices and samples can be cumbersome and information can become outdated rapidly. In addition, the lab technician does not have an effective way to retrieve the current state of samples, instruments, and so on. Current blood and / or plasma skimming laboratories have difficulty preventing duplicate inspection of samples because the records are quickly outdated and effective retrieval of current conditions is inadequate.

In this type of environment, the validity and accuracy of the results may be the most important. In addition, many business factors are involved when considering the speed and efficiency of obtaining results so that the costs associated with managing biological sample screening tasks, sample processing, and products can be used.

summary

In some embodiments, a system for analyzing a biological sample comprises a plurality of centrifuges configured to separate at least some of the plurality of biological samples into a plurality of components, a plurality of subsets of the plurality of components A plurality of pooling devices configured to pool pooled biological components of the plurality of pooled biological components to analyze the plurality of biological samples and / or a plurality of pooled biological components to identify the presence of one or more abnormalities And a processor configured to communicate with and control the plurality of biological sample analyzing devices configured, the plurality of centrifuges, the plurality of pooling devices, and the plurality of biological sample analyzing devices. The system also monitors the operation of the plurality of centrifuges, the plurality of pooling devices, and the plurality of biological sample analysis devices to generate at least one of a warning or a failure indication via a graphical user interface (GUI) A processor configured to track an analysis progress of the sample to generate a plurality of progress indicators through the graphical user interface and to store at least a portion of the tracked progress in a memory, To increase and to increase.

One or more of the above paragraphs may include one or more of the following features. The plurality of biological samples may comprise blood and / or plasma samples. The plurality of biological sample analyzers may be configured to perform at least one of a nucleic acid amplification assay (NAT), an immunohematological assay, or a serological assay. The processor may further be configured to determine the progress of the analysis of the particular sample as it receives a search request associated with a particular biological sample and to generate a progress indication through a graphical user interface. The processor determines the presence of a first external control to prevent release of a biological component to a biological sample analyzer and, upon determining that the first external control is present, when the first external control is released To prevent the biological component from being released to the biological sample analyzer after the first external control to perform an analysis of the biological component. Wherein the processor is further configured to determine the presence of a second external control to prevent release of the biological component prior to a second external control after analysis by the biological sample analyzer, And may be configured to prevent the release of analytical results for biological components until an external control is released.

One or more of the above paragraphs may include one or more of the following features. The processor may generate an alert via a graphical user interface and determine whether the pool is to be analyzed by the one or more biological sample analyzing apparatuses in accordance with a determination that the components of the biological sample are grouped into more than one pool, And generate a warning via a graphical user interface in accordance with a determination that the first component of the first biological sample and the second component of the second biological sample to be analyzed by the single analysis method are analyzed by the one or more sample analysis devices. The processor may be configured to prevent the biological sample from being added to all but one pool, in accordance with a determination that the components of the biological sample are unintentionally grouped into more than one pool. The processor is configured to analyze the potential pool by a first component of a first biological sample that is configured to be analyzed by multiple analyzes by one or more biological sample analyzing devices and a second component of a second biological sample that is configured to be analyzed by a single analysis method by one or more biological sample analyzing devices. May be configured to prevent the first or second component from being added to the pool added to the potential pool and / or to remove the first or second component from the potential pool, in accordance with the decision to include the sample . The processor may determine that the pool responds to the first biological sample analyzer by providing the pool to the same or a second biological sample analyzer after the first biological sample analyzer completes analysis of the pool and / According to the decision, the first biological sample analyzer deconvolutes the pool by providing the pool's components to the same or another biological sample analyzer after the analysis of the pool is completed and / May be configured to provide the components to the same or another biological sample analyzing device after the analysis of the components of the pool is completed, in accordance with the determination that the components of the pool are responsive.

One or more of the above paragraphs may include one or more of the following features. The biological sample can be moved manually or automatically between a plurality of centrifuges, a plurality of pulling instruments, and a plurality of biological sample analyzers through a track system or a workcell. The processor may automatically adjust one or more workflows of the plurality of biological samples based on the unexpected result of one or more of the monitored actions of the plurality of centrifuges, the plurality of pooling devices, or the plurality of biological sample analyzing devices And automatically adjust the tracked progress of the analysis of the plurality of biological samples. The processor may be configured to automatically adjust the workflow based on a delivery schedule of the biological samples. The processor may be configured to automatically adjust the workflow based on the availability of one or more of the plurality of centrifuges, a plurality of pooling devices, a plurality of biological sample analyzing devices, a plurality of reagents, or a plurality of descriptors. The processor may be configured to receive an error message from one or more of the plurality of centrifuges, a plurality of pulling devices, or a plurality of biological sample analyzers and to generate an error message indication via a graphical user interface, One or more hardware errors or software errors, and the workflow is automatically adjusted based on the error message.

One or more of the above paragraphs may include one or more of the following features. Wherein the processor is further configured to determine whether the operation of one or more of the plurality of pooling devices and the plurality of biological sample analyzers is an unintended duplicate and determine whether the operation of the plurality of pooling devices and the plurality of biological sample analyzers May be configured to automatically change the workflow for one or more of the operations of the plurality of centrifuges, the plurality of pooling devices, and the biological sample analyzing device, according to the determination that one or more of the plurality of pooling devices have. The redundancy may include one or more biological samples already planned for biological sample inspection in the analytical instrument and / or a portion of another pool designed for the same inspection in the biological sample analysis apparatus. The redundancy may include one or more biological samples that do not have the same pooling requirement as another biological sample in the same pool.

In some embodiments, a method of guiding and augmenting the automation of a biological sample analysis comprises using a processor configured to communicate with and control the plurality of centrifuges, the plurality of pooling devices, and the plurality of biological sample analyzers Monitoring the operation of the plurality of centrifuges, the plurality of pooling devices and the plurality of biological sample analyzing devices to generate at least one of a warning or a failure indication via a graphical user interface, and tracking the progress of the analysis of the plurality of biological samples Generating a plurality of progress indicators through the graphical user interface and storing at least a portion of the tracked progress in a memory, wherein the plurality of centrifuges comprises at least some biological samples of the plurality of biological samples , And the first and second components Wherein a number of pooling devices are configured to pool a plurality of subsets of the plurality of components into a plurality of pooled biological components and wherein the plurality of biological sample analyzers are configured to pool the plurality of pooled biological components to determine the presence of one or more abnormalities. Or a plurality of pooled biological components of the biological sample.

One or more of the above paragraphs may include one or more of the following features. The method may include determining the progress of the analysis of the particular biological sample and generating a progress indication via a graphical user interface upon receipt of a receipt of a search request associated with the particular biological sample. The method may include displaying a list of items representing behaviors for an operator, wherein at least one of the list of items includes an action item, a time for the action, or an instrument identifier identifier, and the list of items is sorted according to one or more measurements of the urgency of the relevant action. The list of items may include unique identifiers for one or more devices associated with acts of the same type and urgency.

Any one or more of the above paragraphs may include the use and / or operation of the system described herein. One or more of the above paragraphs may perform the steps of the methods described herein. The graphical user interface may be implemented as shown and / or described.

Hereinafter, specific embodiments of the present disclosure will be described by way of example only with reference to the accompanying drawings. In the drawings,
Figure 1 illustrates a workflow of biological sample screening according to some embodiments;
Figure 2 illustrates a screening workflow system in accordance with some embodiments;
3 illustrates a graphical user interface presentation workflow according to some embodiments;
Figure 4 illustrates data used to manage and schedule workflows according to some embodiments;
Figure 5 illustrates the process of managing inspection orders;
Figure 6 illustrates the process of managing the release of test results according to some embodiments;
Figure 7 illustrates a process for evaluating the potential components of a pool to prevent unwanted pooling or testing according to some embodiments;
Figure 8 illustrates the process of determining whether a component of a pool is valid before testing according to some embodiments;
Figure 9 illustrates the process of deconvoluting a reactive pool according to some embodiments;
Figure 10 illustrates the display of an action list for an operator to ensure efficient operation of the system and emission of results in accordance with some of the embodiments.

details

Embodiments Described herein are apparatus and methods for managing biological samples such as blood and / or plasma samples, screening experimental workflows, for example monitoring activities, tracking progress, and generating progress indicators will be. Screening of biological samples such as blood and / or plasma samples The laboratory workflow procedure may include manual procedures to assist in the process of screening and performing diagnostics in the laboratory. There is a need to create, automate and / or track these and other procedures for rapid and accurate processing and management.

The blood and / or plasma screening laboratory workflow system may determine and / or track the current state of the device and may display its status on a graphical user interface representing multiple workflows. The graphical user interface may provide information to the descriptor in real time about each biological sample, each assay, and / or current operating status for each device. This graphical user interface allows a technician to directly observe a particular instrument and / or biological sample without having to manually identify the stage in the workflow for the biological sample.

The blood and / or plasma screening laboratory workflow system may provide chronology of status and results for biological samples. For example, the blood and / or plasma screening laboratory workflow system may display a device state, a biological sample test result, and a workflow associated with a particular biological sample. In addition, the blood and / or plasma screening laboratory workflow system may display the current status of the biological sample. The system can provide a time table of status, display the status of the instrument and biological sample, display components requiring operator attention, and retrieve and display the status of samples and tests. The system can prevent unintended use, including redundancy checking.

The blood and / or plasma screening trial workflow system may implement a graphical user interface display that displays the status of the system according to the corresponding workflow. The status of the system and the status of the workflow of the blood and / or plasma screening and diagnostic experiments can be stored and retrieved in a database. The blood and / or plasma screening laboratory workflow system may evaluate data received from various systems (e.g., accession systems, centrifuge systems, etc.) and determine the current status to display in the graphical user interface.

The graphical user interface may represent the next operator actions required to ensure efficient workflow. Actions include in particular analytical kit replenishment, fluid handling, consumable handling, or waste container emptying. The list of required actions can be sorted in the most urgent order, represented as a time or other priority metric, and categorized based on one or more specific analytical instruments. Multiple analytical instruments that require the same type of attention and have the same urgency can be grouped and identified with the same graphical indicator.

The graphical user interface may include a search that may be used to list the characteristics of the biological sample. Upon entering a biological sample, the blood and / or plasma screening laboratory workflow system may retrieve data from the database associated with the biological sample. The graphical user interface may display a workflow associated with a result of an analysis or procedure performed on a biological sample and / or a biological sample. The graphical user interface may display the current state of the biological sample in each workflow stage.

The graphical user interface may display the current operating state of the system and / or the current state of the biological samples according to a chronological list of stages of the workflow. The technician may use the graphical user interface to display this status and select any of the workflow stages to obtain further details of that particular step and / or the operational status of that system.

Some embodiments of the present invention provide a graphical user interface that allows engineers to efficiently and accurately track biological samples and workflows at lower cost while meeting regulatory requirements such as those prescribed by, for example, FDA, ISO or CLIA Lt; / RTI >

Overview of the biological screening workflow

Figure 1 illustrates a workflow 100 for biological sample screening, such as blood and / or plasma screening, in accordance with some embodiments. The workflow 100 includes an accession stage 102, a centrifuge stage 104, a decap / sort stage 106, a pooler stage 108, An analyzer stage 110, a review stage 112, and a storage stage 114. The workflow 100 may be used, for example, for blood and / or plasma screening.

The registration system of the registration stage 102 may perform the following functions. A laboratory can receive an order of a group of tests or tests for a particular biological sample. When a laboratory receives an order and / or a biological sample, a registration number (e.g., a donor identification number that can be scanned) and / or a self-sample identifier is assigned to the order, test (s) and / . An identifier, such as a donor identifier, may include the number given to the donor via the bar code kit in a collection center where blood or plasma donation takes place. Alternatively, the control number and / or its own sample identifier may be a unique identifier generated by the computer assigned to the sample. The registration number and / or donor identifier may be used to identify the sample as it travels around the laboratory. For example, if a sample is formally received by a medical institution or healthcare services agency, the registration number and / or its own sample identifier may be placed in the sample. The registration and / or own sample identification number is based on the information received from the order and may be used to check for samples, information relating to biological samples, date and time of collection of samples, information for billing purposes, . Each collected sample and / or group of samples may be assigned its own registration number and / or its own sample identifier. A single registration number and / or its own sample identifier may be assigned to a group of biological samples (e.g., blood and / or plasma samples from the same patient have the same accession number) and / or a registration number and / Or a self-sample identifier may be assigned to each biological sample (e.g., each sample of blood and / or plasma from the same patient has a different registration number). In some embodiments, the biological sample is already associated with an identifier. In the subscription stage 102, the registration system can access the identifier. For example, the sample identifier may be pre-placed in a tube in the donation center. The registration system can read bar codes, QR codes, unique identifiers, labels, codes, alphanumeric identifiers, and the like. The laboratory can confirm the arrival of the sample when reading the identifier.

The registration number and / or its own sample identifier may be used in a variety of devices to identify when a biological sample has begun or has completed the test on the device. The registration number and / or its own sample identifier may be used to keep track of each biological sample as it progresses through the workflow 100. The registration number and / or its own sample identifier may be used to assign a particular biological sample to a particular device for a particular time during a particular time period. Thus, the device can read the registration number and / or its own sample identifier for the biological sample to determine whether a correct biological sample has arrived for inspection. The device may send the updated status in the workflow 100 for the biological sample to the blood and / or plasma screening experimental workflow system. Next, the blood and / or plasma screening experiment workflow system may update the graphical user interface to show in real-time the latest state of the samples for evaluation by the technician.

The centrifugation system of the centrifugation stage 104 may perform the following functions. The centrifuge system may include a device that rotates an object about a fixed axis and rotates the object in a circle. The object may be a biological sample. The rotation applies a force perpendicular to the axis of the spin. The centrifugation system may separate some biological samples from a plurality of biological samples into a plurality of components.

In the centrifuge stage 104, a centrifuge can be used to separate the components of the biological sample. The separation may be based on particle size or density. For example, the rotation moves the more dense material and particles radially outward. At the same time, low density objects are displaced and move toward the center of rotation. In the laboratory centrifuge, the dense particles settle to the bottom of the sample tube and the low density material climbs to the top of the sample tube.

In some embodiments, the centrifuge separates blood into cells and serum or plasma. The centrifuge may rotate at a rate of revolutions per minute (RPM) for a specified time. For example, a centrifuge may be specified to operate a particular biological sample at 1000 g RPM for 10 minutes, where g is the relative centrifugal force measured in multiples of the Earth's gravitational field.

The biological sample may be assigned to a centrifuge at a particular time. The centrifugation system can access the biological sample's registration number and / or its own sample identifier to determine when the biological sample will enter and leave the centrifuge system. The centrifugation system may send an update status of a biological sample to a blood and / or plasma screening laboratory workflow system to display real time data to the technician. In addition, the blood and / or plasma screening laboratory workflow system may determine whether the centrifuge system is capable of accepting other biological samples. Thus, the blood and / or plasma screening laboratory workflow system can adjust and optimize the workflow so that suitable biological samples are listed in the centrifuge system. For example, if a system takes longer than expected to perform a test, the blood and / or plasma screening laboratory workflow system automatically and dynamically adjusts the workflow so that other biological samples of higher priority are originally centrifuged Ensure that the centrifugation system is in place prior to the biological sample to be in the system. The blood and / or plasma screening laboratory workflow system may adjust and / or optimize workflow based on the tracked state of one or more instruments and / or samples. The blood and / or plasma screening laboratory workflow system may determine priorities and / or adjustments for one or more instruments and / or samples. The blood and / or plasma screening laboratory workflow system may periodically and / or adjust and / or optimize the workflow in response to activities such as completion or delay of the test.

The cap removal / sorting system of the cap removal / sorting stage 106 may perform the following functions. The decapper system may remove the cap of the sample tube containing the biological sample for examination. For example, the cap remover can automatically remove and / or screw the cap of the screw cap tube with internal or external threads. The sample tube can then be detached from the screw cap and the top open for sampling for further inspection. The cap removal system may also turn the sample tube after removing the cap to remove the cap to remove the cap and / or to prepare the next step in the work space to improve cap removal performance.

A sorter system may classify sample tubes containing biological samples to determine the order and placement of biological samples according to an optimized workflow. The sorting system may sort the sample tubes before and / or after the cap removal system. For example, the sorting system can sort the tubes prior to the cap removal system to reduce the risk of cross-contamination (e.g., when the cap remover moves over an open tube).

The classification system may classify the tubes after cap removal based on the next step of the workflow for each biological sample in the sample tubes. For example, the classification system may determine that several sample tubes containing a particular biological sample have undergone a serological scan. In this case, aggregation analysis is performed to confirm whether the antibody exposed to a specific antigen can cause particle aggregation, a sedimentation test in which antigens are confirmed to be similar by measuring the presence of antibodies in body fluids, Various assays may be initiated, such as Western blot assays, which may aid in confirming the presence of anti-microbial antibodies. They can be used to screen blood and plasma donated samples for infectious diseases to reduce the risk of blood transfusion infection. Another example of an ordered test that can be assessed for classification may include immunohematologic tests that may include study of antigen-antibody reactions and the development of blood diseases and similar phenomena associated with clinical signs. Such tests include blood and / or plasma typing (e.g., blood classification based on the presence or absence of antibodies and the presence or absence of antigenic substances on the surface of red blood cells), cross matching (e.g., multiple blood and / (E.g., compatibility testing through matching of systems), and antibody identification (e.g., identification of proteins primarily produced by plasma cells used by the immune system to neutralize pathogens such as bacteria and viruses). Another example of an ordered test that can be evaluated for classification may include nucleic acid testing, a molecular technique that tests blood donations to reduce the risk of transfusion infections in a recipient, It is often used in.

The puller of the puller stage 108 may perform the following functions. The pooler system can pool sample tubes together to perform biomedical experiments on the pooled biological samples. Pooling the biological samples may be an economical sampling strategy. Since more than one sample can be physically combined into a single pooling unit for analysis, the number of checks can be reduced. The pooling system may pool various biological components into a pooled set of biological components. Pooling of samples can be used in certain blood and plasma screening laboratories for specific nucleic acid assay (NAT) analysis. For example, aliquots of multiple samples may be combined into a single full tube (as described in the package insert of the assay) to enable one test. Pooling information may be provided to the middleware. If the test is negative, all samples may be considered negative and emitted. Alternatively, if the pool is positive, the pool is deconvoluted and the samples can be individually checked again to verify that the sample is responding.

The analysis system of the analysis stage 110 may perform the following functions. The analysis system may analyze the biological sample and / or the pooled biological samples. The analysis system may feed back the results to a blood and / or plasma screening laboratory workflow system. When the analysis system receives the biological sample and / or the pooled biological sample, the analysis system identifies the sample tube (s) and informs the blood and / or plasma screening laboratory Can be reported to the workflow system. After analysis, the assay system can report to the blood and / or plasma screening laboratory workflow system as to whether the biological sample (s) should leave or remain in the assay system. Next, the blood and / or plasma screening laboratory workflow system can determine the next biological sample to reach the analysis system and determine where the recently analyzed biological sample (s) will be moved. The analysis system can analyze the biological sample to determine the presence or absence of abnormality.

The assay system can determine whether blood and / or plasma has a particular compound and / or can determine the level of a compound in blood and / or plasma. For example, the analyzer can measure blood glucose levels in the blood. Some examples of analyzers include cardiovascular (including whole cholesterol, low density lipoprotein, lipoprotein, lipoprotein, high density lipoprotein, triglyceride, c-reactive protein, homocysteine and the like), liver function tests (alkaline phosphatase, GGT, AST (TSH, free T3, whole T3, free T4, whole T4, rT3, etc.), kidney function test (test for creatinine, urea nitrogen, etc.) (Including tests for testosterone, IGF-1, growth hormone, DHEA, estradiol and PSA), carbohydrate tolerance tests (including tests for fasting insulin, fasting glucose, etc.), protein status Tests (including tests for albumin, globulin, etc.), vitamins, minerals and acid / base tests (25-hydroxyvitamin, vitamin b-12, folic acid, (Including tests for leukocytes, neutrophils, basophils, eosinophils, lymphocytes, mononuclear cells, etc.), red blood cells (including red cells), red blood cells (Including tests for cortisol, LDH, uric acid, etc.), hemoglobin, hematocrit, mean corpuscular volume, mean particulate hemoglobin concentration, mean particulate hemoglobin, erythrocyte size distribution width, platelets, . In blood and plasma screening laboratories, analytical systems can identify pathogens, especially including: nucleic acid tests: HIV, HBV, HCV, WNV, Zika and Babesia; Immunoassays: HIV, HBV, HCV, HTLV I & II, Chagas, Syphillis and CMV.

In some embodiments, the assay system can measure different chemicals and other properties in a plurality of biological samples. Such measurements can be made automatically and / or with the help of a minimum of human. The process of analyzing the blood and / or plasma sample may include placing the test tube in a rack, moving the tube along the path and / or placing the tube in a rotating round carousel to make the sample available As shown in FIG.

The movement between the stations (e.g., analysis system, fuller system, etc.) may be automatic, semi-automatic, manual and / or a combination thereof. For example, the sample tube may be automatically transferred from the sorting system to the puller system via the technician, and from the puller system to the analysis system (e.g., by the use of a robot that moves the sample tube). Also, the input of information and data into the software system may be automatic, semiautomatic, manual and / or a combination thereof.

The review system of review stage 112 may perform the following functions. In a review system, the blood and / or plasma screening laboratory workflow system may receive status from a variety of laboratory systems, e.g., registration systems, centrifuge systems, with respect to the status and location of biological samples. The blood and / or plasma screening laboratory workflow system may determine whether a biological sample is underway according to an expected workflow. If the biological sample remains in a particular system for an extended period of time, the blood and / or plasma screening laboratory workflow system can re-adjust the workflow to optimize the workflow of current and other biological samples. If the system in the laboratory provides unexpected test results to the blood and / or plasma laboratory workflow system, the blood and / or plasma laboratory workflow system may rebalance the workflow. For example, if the analyzer reports a positive (or reactive) result of a particular biological sample requiring further testing of the biological sample, the blood and / or plasma screening laboratory workflow system may re-adjust the work- The sample can be further inspected to optimize the workflow of other biological samples.

The storage system of the storage stage 114 may perform the following functions. The storage system can accept biological samples and store them in a storage space. This storage space is the storage space until the next workflow stage arrives and / or a storage space for removal in the laboratory before the blood and / or plasma screening laboratory workflow system determines the next step for the biological sample And / or may be a temporary storage stage.

Biological sample screening workflow system

Figure 2 illustrates a screening workflow system 200 for biological samples, such as blood and / or plasma samples, in accordance with some embodiments. The system 200 includes a system 100 including a centrifuge stage 104, an encapsulation / sorting stage 106, a puller stage 108, an analysis stage 110, a review stage 112 and a storage stage 114 RTI ID = 0.0 > 1 < / RTI > The system 200 may also include resources such as resource availability 204, resource of instruments 206, resource of reagents 208 and resource of people 210 And a resource preparation system (202). The system 200 further includes a management and schedule system 212, a dashboard and control center 214, and a database 216. The screening workflow system 200 may include one or more processors and one or more memories. The one or more processors may perform control, monitoring, and the like of one or more biological sample screening devices described herein.

The management / scheduling system 212 of the screening workflow system 200 may determine a workflow for a biological sample. For example, when a number of urgent biological samples arrive at a laboratory, the management / scheduling system can determine the urgency and amount of these biological samples by evaluating sequences, biological samples, and the like. Next, the management / scheduling system prioritizes these biological samples so that these biological samples can be compared to the registration system of the registration stage 102, centrifugation stage 104 of the centrifuge stage 104 prior to other previously- The analysis system of the analysis stage 110, the review system of the review stage 112 and the storage stage 114 of the cap removal / classification stage 106, the fuller system of the pooler stage 108, the analysis system of the analysis stage 110, Through the storage system of FIG.

The management / scheduling system 212 may monitor the resource availability 204 to determine and / or optimize the workflow for biological samples. The management / scheduling system 212 may evaluate the availability of the device 206, such as an apparatus for performing an inspection. For example, if there are a sufficient number of devices to perform the steps of the centrifuge stage 104 but the supply of restricted devices to perform the steps of the cap removal / classification stage 106 is restricted, Prioritize biological samples that need to be sorted so that they can receive the centrifuge stage 104 prior to biological samples that can bypass the cap removal / classification stage 106.

The management / schedule system 212 may evaluate the availability of the reagent 208 to determine and / or optimize the workflow for the biological sample. For example, if there is data for a reagent 208 of a limited supply for the analysis stage 110 for one particular test but a new supply of reagent reaching the lab within three hours, the management / (212) initiates a workflow for biological samples of a set number, wherein the reagent (208) of the limited feed amount evaluates the set number of biological samples until a sample of the new feed amount arrives May be used to place the remaining biological sample in storage 114. In some embodiments, the management / scheduling system 212 may display to the operator recommendations for reagent preparation and loading of reagents on the instrument or removal of reagents from the instrument. In some embodiments, the GUI may display to the operator recommendations and / or requirements for workflow changes. In some embodiments, the GUI may allow an operator to make a selection based on the information and proceed with the workflow, for example allowing the operator to change the workflow based on efficiency.

The management / scheduling system 212 may monitor the availability of the person 210 (e.g., a descriptor) to determine and / or optimize the workflow for the biological sample. For example, if the cap removal / classification stage 106 may be performed manually by the technician at a slower rate and may be performed automatically by the robot at a faster rate, the management / May schedule the workflow so that biological samples that are to be analyzed quickly after direct contact with the environment can be scheduled for automatic cap removal and classification while other biological samples may be scheduled for the cap removal / So that it can be instructed.

Data relating to devices, reagents, people, and / or biological samples may be stored in a database 216 that may be stored in one or more memories. The database 216 may include one or more internal and / or external data sources. In some embodiments, one or more of the above-described data sources and data stores may be stored in a relational database such as DB2, Sybase, Oracle, CodeBase, and Microsoft® SQL Server, as well as in a flat-file database, an entity relationship database ) And an object-oriented database and / or a record-based database.

The system (e.g., management / scheduling system 212) may access the database 216. The database 216 may be stored in a data store. The system may access the database 216 over the network or may directly access the database 216 via the I / O device and interface. A database 216 that stores one or more data sources may reside in one of the systems and / or may be external to the system.

The dashboard and control center 214 may generate graphical user interface data for display to a user, such as a technician. The dashboard and control center 214 may display updated workflow information for one or more biological samples and / or test tubes. The dashboard and control center 214 may display the results of the inspection of biological samples. In addition, the dashboard and control center 214 may indicate the availability of devices, reagents, and people.

Graphical user interface

Figure 3 illustrates one embodiment of a graphical user interface representing a workflow according to some embodiments. As shown, the graphical user interface represents the following workflow: HIV, Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Zika Virus, West Nile Virus (IH) workflow (IH workflow) for an antigen-antibody reaction, and for screening for antibodies, for example, a nucleic acid amplification test (NAT) workflow (NAT workflow) for infectious diseases such as WNV, Parvo, Serum workflow. The graphical user interface may be displayed under the control of one or more processors, such as one or more processors of the screening workflow system 200.

In some embodiments, the NAT workflow includes a NAT access stage, a centrifuge stage, a cap removal and rack stage, a puller stage, an analysis stage (shown as "Panther 2" in the figure), a quality assurance (QA) , Cap and rack stages, short-term storage stages and long-term storage stages. In this example, the centrifugal device # 5 shows the status of a fatal hardware error. The centrifugation system can identify errors such as hardware errors and send error messages to the management / schedule system. The management / scheduling system may decide to start a fix for centrifuge # 5 from the error message. The management / scheduling system can optimize the workflow so that future workflows do not use centrifugal device # 5 but have access to other workflow stages included in the NAT workflow.

The graphical user interface shows that the current state of the analyzer (e.g. Panther 2 shown in the figure) ends within 20 minutes leaving 50 checks. The management / scheduling system can receive this information from the analysis system and optimize the workflow to avoid using 50 checks and sending the workflow to the analyzer after 20 minutes.

In some embodiments, the IH workflow comprises an EDTA sample tube registration stage, a centrifuge stage, a cap removal and rack stage, an antibody screening assay stage, a classification stage, an IH analysis stage, a QA status stage, a cap and rack stage, And a long-term storage stage.

In some embodiments, the serum workflow comprises a CLOT sample tube registration stage, a centrifuge stage, a cap removal and rack stage, a sorting stage, a serum analysis stage, a QA status stage, a cap and rack stage, a short term storage stage, .

The graphical user interface may include a delivery schedule for the samples to arrive at the lab. The delivery schedule is based on the total number of samples (e.g., 1,600 total samples) and the number of samples for a particular period of time (e.g., 150 at 10am, 350 at 11am, 150 at 12pm) 350 at 1 PM, 250 at 2 PM, and 350 at 5 PM).

The management / scheduling system can track the progress of the analysis of biological samples and generate progress indicators through a graphical user interface.

In some embodiments, the management / scheduling system may identify the relevant instrument, biological sample, reagent and / or descriptor. The relevant instrument, biological sample, reagent and / or technician may be automatically identified via user input and / or according to criteria set by the management / scheduling system, as described in more detail below. The management / scheduling system may determine the progress of the associated instrument, biological sample, reagent and / or technician, and may display the progress indicator via a graphical user interface.

Workflow management and scheduling

Figure 4 illustrates data used to manage and schedule workflows according to some embodiments. A manage / schedule system, such as system 212, may monitor the operation of various systems to generate a warning or failure indication via a graphical user interface. The management / scheduling system 212 may store the tracked progress in a database. The management / scheduling system 212 may be configured to prevent errors, perform the necessary checks, inform the operator of the status, direct the user to perform a specific operation, prepare the document, and perform subsequent checks (e.g., reflex / retest) and / or gather information from the computing system to help form conclusions and formats from the reviewer results.

The management / scheduling system 212 may receive inputs from various systems. The systems can be located throughout the lab. The management / scheduling system 212 may include stages of the workflow illustrated in FIG. 1, e.g., a registration system 424, a centrifuge system 426, a cap removal / a sort system 428, a pooler system 430, an analyzer system 432, a review system 434 and a storage system 436 can do.

The management / scheduling system 212 may receive user input data 402. For example, the management / scheduling system 212 may receive input from a descriptor. The input may be data that may affect the workflow. For example, a technician may enter information about hardware or software errors in the system, results of tests performed by the analyzer, situations where biological samples are deployed or removed from the system, and the like. The management / scheduling system 212 may then optimize the workflow based on user input.

The management / scheduling system 212 may receive information from the blood and / or plasma center 404. The blood and / or plasma center may include information such as blood and / or plasma type 408, test order 409, and the like of the sample. The management / schedule system 212 may receive release times of the biological samples 412.

The management / scheduling system 212 may receive sensor data 414. The sensor data may be obtained from a system of blood and / or plasma screening and diagnostic laboratories.

The management / scheduling system 212 may receive data from track systems 420. The tracking system 420 may perform tracking of data for workflow management. For example, the tracking system 420 may track inventories, reagents, technicians, and / or biological samples throughout the laboratory.

The management / scheduling system 212 may receive sample integrity data from specimen integrity systems 422. The sample integrity system 422 may check the integrity of the sample at a particular stage of the workflow during and / or after the biological sample completes the workflow before the biological sample is placed in the workflow. The sample integrity system 422 may examine the samples manually and / or automatically. For example, a classifier with such a function can inspect a sufficient amount, and after centrifugation, it can be tested for dyslipidemia and hemolysis based on the color of the sample.

For example, the management / scheduling system 212 may determine not to send a check order to the analyzer if the sample integrity check fails. The management / scheduling system 212 can prevent such emissions until an error order comes in from the analysis system and a user order is provided to allow such emissions.

The management / schedule system 212 may receive data from the system of FIG. 4 for multiple workflows and may evaluate the received data in multiple workflows to verify the status of biological samples. The management / scheduling system 212 may also evaluate such information to determine the status of various systems within the laboratory. Next, the status and various workflows of the biological sample and system may be displayed on the graphical user interface. The technician can view the current state of the current operating state, the overall operating state of the workflow, or the performance of the device device for each element of the workflow without searching for a biological sample.

Manage Inspection Orders

FIG. 5 illustrates one embodiment of a process 500 for managing test sequences in accordance with some implementations. The process 500 may be performed by a screening workflow system such as the system 200. In some implementations, the process 500 may be implemented by a management / scheduling system, such as the system 212. The process 500 enables the configuration of external control. The outcome of the configuration of the external control can affect the release of the sample test conclusions for a period of time and / or for multiple tests. The affected test may be performed before or after external control is performed. The configuration of the external control may be consistent with the requirements of the laboratory procedure. At block 502, the process 500 loads a calibrator. The calibrator may include a manufacturing sample containing expected results that are known when analyzed by the analyzer. For example, Procleix Ultrio Elite can include six positive calibrator replicates and three voice calibrator clones. EQCs can include external quality control with known expected results and can be obtained by examining third party experiments. The EQCs may be executed at a frequency related to the number, time, and / or combination of tests.

At block 504, the process 500 determines whether the configuration of the external control is required before loading the sample. If the configuration of the external control is required before testing the sample, the process continues to block 514 where the configuration of the external control is loaded. The control set may include a flag indicating whether the set of calibrators and / or the set of controls is valid. A valid calibrator or control can produce the expected result when passing through the analyzer. For example, in the case of qualitative inspection, a positive calibrator / control may indicate a reaction state for the test and a calibrator / control may indicate a non-reaction state. The quantitative calibrator and control may be valid when the result is in the expected predefined range.

At block 516, the process 500 determines whether the active calibrator and / or external control needs to be completed before the sample is loaded. If so, the process 500 waits for a valid configuration of these calibrators and / or controls and continues at block 508. If the process 500 does not require a valid calibrator and / or external control configuration, the process proceeds to block 508 without waiting for a valid calibrator and / or configuration of external control.

At block 508, an order is sent to the analyzer for pipetting the sample. The sample is either manually loaded or automatically transferred to the analyzer and ready for pipetting.

At block 504, if no external control configuration is required prior to loading the samples, the process proceeds to block 506 where the passing calibrator is used to initiate sample loading and testing It is determined whether or not it is required. If so, the process proceeds to block 512 where the process 500 determines whether the calibration passes. If a calibration result is not required to start the sample test, the process proceeds to block 508 where an order is sent to the device to begin the sample test.

At block 510, the process 500 determines whether the configuration requires loading of external control after sample loading. If so, the process proceeds to block 518 where the configuration of the external control is loaded. The configuration of external control loaded into block 518 may include a similar configuration of external control loaded into block 514. [ The timing of loading the EQC can be defined in an individual laboratory, and the samples can be loaded into groups for various tests run on the analyzer. After loading the configuration of the external control, the process proceeds to block 512 where the process 500 may determine whether the calibrator is passing. The calibrator can proceed as if they were samples to be examined on the instrument. The instrument can identify when the calibrator is loaded and / or the instruments can label results accordingly from the calibrator. Information about whether the calibrator passes (e.g., the expected result for the calibrator type) or whether it failed can be communicated to the middleware by the instrument.

At block 512, once the calibrator is passed, the process can proceed to transfer the results to the middleware. The analytical test results (sample reactivity, sample non-reactivity, calibrator valid / invalid, EQC valid / invalid) can be delivered to the middleware. If the calibrator has not passed, the process returns to block 502. In some embodiments, if the calibrator does not pass, the results of using the reagent kit on the instrument are considered valid, and valid calibrator results may be required to obtain valid sample results.

Management of release of test results

Figure 6 illustrates one embodiment of a process 600 for managing the release of test results in accordance with some embodiments. The process 600 may be implemented by a screening workflow system such as the system 200. In some implementations, process 600 may be implemented by a management / scheduling system, such as system 212. The process 600 can direct the release of the test results. The emission of test results may be based on the configuration of the external control, as the case may be. The configuration of the external control can prevent the release of certain biological samples while allowing the release of other biological samples. In some embodiments, external control may be loaded into the analyzer.

At block 602, the same result as the test result for the biological sample by the analysis system is received from the instrument. The results are evaluated at block 604 to determine if they will respond. Reactive test results can include positive samples for testing (e. G., Infection of pathogens). A reactive pool may mean that one or more components in the pool have been infected.

If the result is reactive, a conclusion is applied to the test for the sample at block 606 and a workflow is constructed accordingly at block 608. [ The conclusion may include an intermediate result or a final result indicating whether the sample has been infected, the calibrator provided and whether the EQC result is valid. The workflow can be configured by the laboratory. For example, a confirmation check may be required if the sample is found to respond first. As another example, a workflow can include how many positive retest results will determine the final positive result. At block 610, the process 600 may release the result from the device. The results can be emitted to the next level of the laboratory information system (LIS), GUI and / or workflow where the technician can see the results.

At block 614, process 600 may determine whether configuration of external control is required. The order of the EQCs may vary according to the protocols set in the laboratory and / or may be in the order before / after determining the reactivity and / or after determining the reactivity. If the configuration of the external control is not required, at block 612, the process 600 may perform additional checks, if possible. For example, process 600 may check whether the reagent is valid, whether the quality control review and / or operator review is valid, and so on. The process 600 may then release the results from the device.

At block 614, if configuration of external controls is desired, process 600 may determine if the checked external controls are valid. If they are valid, the process may proceed to block 612 where further testing may be performed, and test results are emitted at block 610. At block 616, if external control is not valid, then at block 618, a new test order is required (e.g., reloading the biological sample). In some embodiments, if the calibrator or EQC result is not valid, the test result can not be trusted.

FIG. 7 illustrates a process 700 for evaluating the potential components of a pool to prevent unwanted pooling or testing, according to some embodiments. The process 700 may be implemented by a screening workflow system, such as the system 200. In some implementations, process 700 may be implemented by a management / scheduling system, such as system 212. An unwanted pool may be a part of another pool that has already been planned for the same inspection, or may contain components that do not have the same pooling requirements as other biological samples of that pool. For example, potential pools may have components that are not all pooling requirements because some components must be pooled for two analyzes and the remaining components must be pooled for a single analysis.

The process 700 may determine a default workflow that includes workflow steps, rules, and procedures. Figure 7 shows an example of a workflow that includes a pooling step if a pool is needed, and also checks for a valid pool result if a pool is needed. At block 702, process 700 may receive an order for inspection from a laboratory information system (LIS).

At block 704, process 700 may check if the inspection order is duplicate. The duplication may include unwanted pools and / or checks and vice versa. The duplication may include re-executing the verification check (e.g., because the initial check is reactive). The unwanted duplication may already be part of another pool or already checked individually.

If the process 700 determines that the inspection order is redundant, the inspection sequence is maintained at block 706. [ One advantage is that it saves time and resources for the experiment because there is no need to perform a workflow for the inspection order. Also, the results for the inspection order can be reported if the duplicate inspection order has already been performed previously. The technician can manually determine what to do with the sample according to the laboratory procedure.

If the process 700 determines that the inspection order is not redundant, the process may proceed to block 708. [

At block 708, process 700 may determine whether a biological sample of the inspection order can be pooled with other biological samples for inspection. If the process 700 determines that the biological sample can be pooled with other samples, the process may send the biological sample to the pooling system and begin a full workflow procedure at block 710. [ Then, at block 712, the inspection order is performed and the biological sample can be analyzed. The workcell may comprise a group of analyzers connected to the automation system. If the process 700 determines that the biological sample does not need to be pooled, the inspection order may be performed at block 712 and the biological sample analyzed. The test results may be generated at block 714 based on the performance of the inspection order at block 712. [ Panther AR / Workcell Analyzer can be used to perform inspection orders and generate inspection results. The analyzer may include an analyzer connectable to the automated system.

The working cell can carry out the inspection order by conveying the biological sample to the appropriate equipment. Based on the pipette condition, an error handling workflow step may be generated at block 716. [

At block 718, process 700 may determine whether the inspection order is duplicate. In some embodiments, more resolution options may be used than after the test if duplicates are detected before the test. If the process 700 determines the presence of redundancy, the process proceeds to 720, which processes the redundancy. The laboratory can define the procedure to continue the exam and / or to re-execute the pool according to the identified duplicates. In some embodiments, redundancy may be required to obtain valid results or to perform validation checks. In some embodiments, the redundancy check may include documentation describing why the redundancy check situation occurs.

Otherwise, the process 700 proceeds to block 722 where the test results are evaluated for reactivity. If the test result is responsive, at block 724, process 700 determines whether the biological samples have been pooled. If the biological samples have been pooled, at block 726, the process 700 may deconvolute the test orders with each individual test order and / or biological sample, review the test results at block 728, Can be performed. In some embodiments, the steps may include confirmation and / or discrimination tests for multiplex analysis. If the process 700 determines that the biological sample has not been pooled, an additional step may be performed at block 728. [ At block 730, the test results may be sent to the LIS.

At block 722, if the test result is not reactive, the validity of the test result is checked. Block 722 may include the results from the analyzer. Non-responsive test results from the analyzer may require that the control test be validated so that the end result is valid. The configuration of the external control at block 736 and the external quality control data at block 738 may be used to determine the validity of the test results. If the test result is valid, the test result may be sent to the LIS in block 730. [ If the test result is not valid, a message may be sent to process 700 that the test has been improperly processed and the test result is not paying.

Pool Validity

Figure 8 illustrates a process 800 for determining whether a component of a pool is valid prior to testing according to some embodiments. The process 800 may include a registration system 802, a pooler system 804, a middleware system 806, an analyzer group system 808, and an analyzer system 808. [ 810). ≪ / RTI > In some embodiments, middleware system 806 is similar to a management / scheduling system, such as system 212.

In the registration system 802, the biological sample ID can be assigned to the biological sample by the process 800 and passed to another system, such as the middleware system 806. In the analyzer system 810, the states of the analyzer and other systems may be generated and transmitted to other systems, such as middleware and / or analyzer group systems.

At middleware system 806, a review order may be received 814 from the LIS and at block 816, middleware system 806 may receive a delivery schedule. The delivery schedule may include an estimate of the delivery time to the donation sample batch laboratory of the donation center. The delivery schedule can be pre-populated. The delivery schedule can be sent automatically at the donation center or manually entered at the previous workflow stage by the lab personnel. The middleware may also estimate the time at which the placement of the test results is available and expected to be delivered to the customer.

In order to meet the customer ' s result emission expectations, the transmission schedule may be used to optimize the schedule of samples and tests before a new sample is loaded into the input module of analyzer group 808 (work cell). The resulting emission schedule can be calculated based on the type and number of tests currently being performed on the test and / or analyzer that have not yet been performed. The analyzer group system 808 generates a summary state and uses the summary to be used in conjunction with the sample delivery schedule 816 in the middleware system 806 to manage the sample inspection and optimize the return time (TAT) for the laboratory customer To the middleware system 806.

The registration system 802 may register the inspection order (812). The registration can occur through a bar code on the sample tube. The registration can identify the nature of the test order and / or biological sample, such as the tube type or whether the sample is pooled. The registration system 802 may send the information to another system. For example, the registration system 802 may send the sample ID and the number of tubes to the middleware system 806.

The middleware system 806 may manage the received inspection order (818). For example, the inspection order can be managed based on whether the analysis, the tube and / or the biological sample will be pooled for each inspection. The determination of whether or not the probe can be pooled can depend on the analysis (type of test) and / or when the last reactivity test was identified at the donor site. The non-pool sample ID and / or the inspection order may be transmitted by the middleware system 806 to the analyzer group system 808. Some experiments may not include pooling and / or may not pool a subset of checks. Some NAT checks can be pooled. A donor's sample can be subjected to a number of other tests. In some embodiments, a subset of components is pooled. In some embodiments, the biological components are not stored.

The middleware system 806 may check whether a sample is unintended duplication. For example, the sample may be part of another pool already scheduled for the same test, or may be a sample without the same pooling requirement as other biological samples in the pool. If the samples can be pooled, the middleware system 806 may send an instruction to the pooler system 804 to pool the classified NAT samples. The pool ID and configuration sample ID may then be transferred from the pooler system 804 to the middleware system 806. Otherwise, the middleware system 806 may alert the operator (e.g., the same sample is in two pools) (824). The pool ID and inspection order may be sent from the system 806 to the analyzer group 808 for performing analysis on the pooled samples.

Reactive pool

Figure 9 illustrates a process 900 for deconvoluting a reactive pool according to some embodiments. The process 900 may be performed by a screening workflow system such as the system 200 or the system 200 shown in FIG. In some embodiments, process 900 may be performed by a management / scheduling system, such as middleware 806 or system 212. Deconvolution in this context may include one or more individual samples (S) may be identified by examining each configuration sample.

The process 900 may begin at block 902, and at block 904 biological samples may be pooled. At block 906, the biological samples are inspected. At block 908, process 900 may determine whether the pool is responsive. The reactive pool can be processed in one of several analyzers. If the process 900 determines that the pool is unresponsive, the results may be released to the LIS at block 910, and the process may be terminated.

If the process 900 determines that the pool is responsive, the constituent sample may be examined at block 912. Each individual biological sample can be examined. That is, an individual donor test (IDT) may occur. If pooling is not required, the process may begin at block 914 and proceed to block 912.

At block 916, process 900 checks whether each sample responds. If the sample does not respond or react, the results may be released to the LIS at block 918 or 920. In some embodiments, even if the pool reacts, the results of the sample of the pool may be released to the LIS. In some embodiments, the sample is a valid result and can be released to the LIS regardless of whether the pool responds or not. In some embodiments, the laboratory can verify whether blood, plasma, and / or organ donations can be used. In some embodiments, other steps may be taken after block 916 if the sample responds after 920 (e.g., retest and / or progressive discrimination for multiplex analysis).

Display of a list of actions for operators

FIG. 10 illustrates an indication 1000 of an action list for an operator to ensure an efficient manipulation of the system and release of results, in accordance with some embodiments. In some embodiments, the list of actions may be displayed to the operator with a list of behaviors that contain information useful to the operator. In some embodiments, the displayed behavior list includes refill tips, refill reagents, empty waste, loading of sample batches (es) ), One or more action items, such as unload completed samples, prepre reagents, and the like. In some embodiments, the graphical user interface displays representative images of one or more behavior items.

In some embodiments, the displayed behavior list may include an estimated amount of time until a particular action is performed. In some embodiments, the amount of time may be indicated by an increase in seconds, minutes, hours, time periods, morning, afternoon, evening, day of week, date, In some embodiments, the amount of the item may be displayed. For example, five refill tips may be suggested and / or required for device ID P100, and ten refill tips may be restricted and / or required for device P200.

In some embodiments, the displayed action list may include an identifier for the device, such as a device identifier. As shown at 1000, the behavior items may be classified based on a measure of urgency (e.g., the amount of time remaining before one or more actions are taken). In some embodiments, the behavior items may be categorized into device identifiers, alphabetical order, and the like. Item lists can be grouped according to urgency, action item, device ID, etc. (Example 1000 shows grouping according to the action items classified according to urgency).

Other changes

While the foregoing describes some embodiments related to blood and / or plasma screening, the disclosed systems and methods can be applied to screening of biological samples other than blood and / or plasma. Such biological samples may include urine, tissue, cells, and the like. Any value such as the threshold value, the threshold value, the duration, etc. provided herein can be an approximate value since it is not an absolute value. In addition, any threshold, threshold, period, etc. provided herein may be fixed or changed automatically or by the user. Also, as used herein, relative terms such as greater than, greater than, or less than the reference value are meant to include the same reference value. For example, exceeding a positive value reference value may include a value equal to or greater than the reference value. Also, as used herein, relative terms relative to a reference value, such as greater than, greater than, less than, and the like, are used to refer to a reference value, such as an inverse of a disclosed relationship, such as below, below, But also includes the reciprocal of the relationship. Also, blocks of various processes may be described in terms of determining whether a value meets or does not meet a particular threshold, but the blocks may be, for example, (i) less than or greater than a threshold value, or (ii) May be understood in terms of values that meet or do not meet the threshold.

It is to be understood that the features, materials, features, or groups described in connection with the specific embodiments, embodiments, or examples may be applied to any other aspect, embodiment, or embodiment as described herein, as long as they are compatible therewith. It is noted that all steps of the present disclosure (including any appended claims, abstract and drawings), or any method or process disclosed herein, are intended to encompass any and all such features or steps, Can be combined. The protection is not limited to those of any of the foregoing embodiments. Said protection may be any novel or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novel combination or any combination of the steps of any method or process disclosed herein. New or any novel combination.

While specific embodiments have been described, these embodiments are provided by way of example only and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be implemented in a variety of different forms. In addition, various omissions, substitutions and alterations can be made in the form of the methods and systems described herein. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the process shown or described may be different than those shown in the figures. Depending on the embodiment, certain of the steps described above may be eliminated, and other steps may be added. For example, the order of actual steps or steps taken in the disclosed process may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be eliminated, and other steps may be added. For example, the various components shown in the figures may be implemented as a processor, controller, ASIC, FPGA, or software or firmware on dedicated hardware. Hardware components such as controllers, processors, ASICs, FPGAs, etc. may include logic circuitry. Furthermore, the features and attributes of the particular embodiments described above may be combined in different manners to form different embodiments, all of which are within the scope of the present disclosure.

Although the present disclosure includes specific embodiments, examples, and applications, those skilled in the art will readily appreciate that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses, including embodiments that do not provide all of the features and advantages described herein And obvious variations and equivalents thereof. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments of the subject matter, but may be defined by the claims set forth herein or as set forth hereinafter. May, "" could, "" might "or" may ", unless otherwise specified, or otherwise understood in the context in which they are used, ) "Is intended to convey that, in general, certain embodiments and other embodiments may or may not include a particular feature, element, or step. Accordingly, such conditional language is intended to encompass, in the case of more than one embodiment, the features, elements, or steps in any manner whatsoever, or one or more embodiments may use these features, elements, or steps without employing or using user input or prompting But is not intended to generally mean that it includes operations to determine whether it is included or performed in any particular embodiment. The terms " comprising, "" including," " having ", and the like are synonymous and used collectively in an unlimited manner and do not exclude additional elements, Do not. Also, the term "or" is used in a generic sense (not used in an exclusive sense), for example, when used to link a list of elements, the term " . Also, as used herein, the term "each" may mean any subset of the set of elements to which the term "each" applies, in addition to having its ordinary meaning.

An associative language such as "at least one of X, Y, and Z " is understood as a commonly used context to convey that an item, term, etc. may be X, Y, or Z unless otherwise specifically stated. Thus, such a connection language is not intended to generally mean that a particular embodiment requires the presence of at least one of X, and at least one of Y and Z. [

As used herein, terms such as "about", "about", "generally", and "substantially" are used herein to refer to the stated value, amount, Value, quantity, or characteristic close to the characteristic. By way of example, the terms "about," " about, "" generally," and "substantially" mean within an amount of less than 5%, less than 1%, less than 0.1% can do. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to an angle of about 15 degrees, 10 degrees, 5 degrees, 3 degrees, Means a value, amount, or characteristic that deviates.

The scope of the present disclosure is not intended to be limited by the specific disclosure of this section or the specific disclosure of the preferred embodiments elsewhere herein and may be defined by the claims set forth in this section or elsewhere herein or presented in the future . The language of the claims is to be interpreted broadly based on the language used in the claims and is not limited to the embodiments described herein or described during the enrollment of the present application and such embodiments are to be construed as non-exclusive do.

Claims (23)

A system for analyzing a biological sample, the system comprising:
A plurality of centrifuges configured to separate at least some of the plurality of biological samples into a plurality of components;
A plurality of pooling devices configured to pool a plurality of subsets of the plurality of components into a plurality of pooled biological components;
A plurality of biological sample analysis devices configured to analyze the plurality of biological samples and / or the plurality of pooled biological components to identify the presence of one or more abnormalities;
A processor configured to communicate with and control the plurality of centrifuges, a plurality of pooling devices, and a plurality of biological sample analyzing devices,
The processor
Monitoring the operation of the plurality of centrifuges, the plurality of pooling devices and the plurality of biological sample analyzing devices to generate at least one of a warning or a failure indication via a graphical user interface;
Track progress of the analysis of the plurality of biological samples to produce a plurality of progress indicators through the graphical user interface;
Wherein the processor is further configured to store at least a portion of the tracked progress in memory,
Wherein the system is configured to induce and increase automation of biological sample analysis. 2. The system of claim 1, wherein the plurality of biological samples comprises blood and / or plasma samples. 3. The system of claim 1 or 2, wherein the plurality of biological sample analyzing devices are configured to perform at least one of a nucleic acid amplification test (NAT), an immunohematological test, or a serological test. 4. The processor of any one of claims 1 to 3, wherein the processor is further configured to determine the progress of the analysis of the particular sample and generate a progress indication via a graphical user interface as it receives a search request associated with a particular biological sample ≪ / RTI > 5. A system according to any one of claims 1 to 4, wherein the processor
Determining the presence of a first external control to prevent release of the biological component into the biological sample analyzer,
In accordance with a determination that said first external control is present, to prevent release of said biological component to said biological sample analyzing device after said first external control to perform an analysis of the biological component until said first external control is released . ≪ / RTI > 6. The apparatus of claim 5, wherein the processor
Determining the presence of a second external control that prevents release of the biological component prior to a second external control after analysis by the biological sample analyzer,
Wherein the second external control is further configured to prevent emission of an analysis result for a biological component until a second external control is released, in accordance with the determination that the second external control is present. 7. The system according to any one of claims 1 to 6, wherein the processor
Generating an alert via a graphical user interface, upon determining that the components of the biological sample are grouped into more than one pool,
Determining that the pool comprises a first component of a first biological sample configured to be analyzed by multiple analytical methods by one or more biological sample analyzing instruments and a second component of a second biological sample configured to be analyzed by a single analytical method by one or more biological sample analyzing instruments , The system further configured to generate an alert via a graphical user interface. 8. The system of claim 7, wherein the processor is further configured to prevent the biological sample from being added to all but one pool, in accordance with a determination that the components of the biological sample are unintentionally grouped into more than one pool. 9. The system according to any one of claims 1 to 8, wherein the processor
The potential pool includes a first component of a first biological sample configured to be analyzed by multiple analytical methods by one or more biological sample analyzing instruments and a second component of a second biological sample configured to be analyzed by a single analytical method by one or more biological sample analyzing instruments Wherein the first or second component is further configured to prevent the first or second component from being added to the pool. 10. A method according to any one of claims 1 to 9, wherein the processor
According to the determination that the pool responds, the first biological sample analyzer may provide the pool to the same or another biological sample analyzer after the analysis of the pool is completed and /
According to the determination that the pool responds, the first biological sample analyzer deconvolutes the pool by providing components of the pool to the same or another biological sample analyzer after the analysis of the pool is completed, and /
Wherein the system is further configured to provide the components to the same or another biological sample analyzer after the analysis of the components of the pool is complete, in accordance with a determination that the components of the pool are responsive. 11. A method according to any one of claims 1 to 10, wherein the biological sample is conveyed between the plurality of centrifuges, the plurality of pooling devices, and the plurality of biological sample analyzers, system. 12. The apparatus of any one of claims 1 to 11, wherein the processor
Automatically adjusting one or more workflows of the plurality of biological samples based on one or more unexpected results of the monitored operations of the plurality of centrifuges, the plurality of pooling instruments, or the plurality of biological sample analyzing instruments, Wherein the system is further configured to automatically adjust tracked progress of analysis of a plurality of biological samples. 13. The system of claim 12, wherein the processor is further configured to automatically adjust a workflow based on a delivery schedule of biological samples. 13. The system of claim 12, wherein the processor is further adapted to automatically adjust the workflow based on the availability of one or more of the plurality of centrifuges, a plurality of pooling devices, a plurality of biological sample analyzing devices, a plurality of reagents, ≪ / RTI > 15. The system according to any one of claims 1 to 14, wherein the processor
An error message is received from one or more of the plurality of centrifuges, the plurality of pooling devices or the plurality of biological sample analyzers
Wherein the error message is further configured to generate an error message indication through a graphical user interface, wherein the error message includes one or more hardware errors or software errors, and the workflow is automatically adjusted based on the error message. 16. The system according to any one of claims 1 to 15, wherein the processor
Determining whether the operation of one or more of the plurality of pooling devices and the plurality of biological sample analyzers is an unintended duplication,
Wherein the plurality of pooling devices and the operation of the plurality of biological sample analyzing devices are selected from among the operations of the plurality of centrifuges, the plurality of pulling devices, and the biological sample analyzing device, The system further configured to automatically change the workflow for one or more duplicate operations. 17. The system of claim 16, wherein the redundancy comprises one or more biological samples that are part of another pool that has already been scheduled for the same biological analyzer. 17. The system of claim 16, wherein the redundancy comprises one or more biological samples that do not have the same pooling requirements as another biological sample in the same pool. A method for inducing and increasing automation of biological sample analysis, said method comprising:
Using a processor configured to communicate with and control the plurality of centrifuges, the plurality of pooling devices, and the plurality of biological sample analyzers,
Monitoring at least one of a plurality of centrifuges, a plurality of pooling devices, and a plurality of biological sample analyzing devices to generate at least one of a warning or a failure indication via a graphical user interface,
Tracking progress of an analysis of a plurality of biological samples to generate a plurality of progress indicators through the graphical user interface,
Storing at least a portion of the tracked progress in a memory,
Wherein the plurality of centrifuges are configured to separate biological samples of at least some of the plurality of biological samples into a plurality of components,
Wherein the plurality of pooling devices are configured to pool a plurality of subsets of the plurality of components into a plurality of pooled biological components,
Wherein the plurality of biological sample analyzers are configured to analyze the plurality of biological samples and / or a plurality of pooled biological components to identify the presence of one or more abnormalities. 20. The method of claim 19, further comprising determining the progress of the analysis of the particular biological sample as it receives a search request associated with a particular biological sample and generating a progress indication through a graphical user interface. 21. The method of claim 19 or 20, wherein the method further comprises displaying a list of items representing behaviors for an operator,
Activity item, amount of time for that action, or
Including the device identifier,
Wherein the list of items is sorted according to one or more measures of urgency of related behaviors. 22. A method according to any one of claims 19 to 21, wherein the list of items comprises a unique identifier for one or more devices associated with acts of the same type and urgency. A method for using and / or operating the system of any one of claims 1 to 18.

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